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Laboratory Manager Design Verification and Validation R and D

Company: Medline Industries, Inc.
Location: Mundelein
Posted on: January 15, 2022

Job Description:

Medline Industries, LP has an immediate opening for a Laboratory Manager - Design Verification and Validation. This position will be responsible for managing the daily operations and staff of the Medline corporate Design Verification and Validation Laboratory (Mundelein Il). This position will manage a team of engineers and laboratory technicians that are responsible for performing mechanical and electrical design verification testing in support of New Product Development (NPD) and Sustaining projects across all of Medline%26rsquo;s product divisions.

Major Responsibilities:
Manage day to day laboratory activities, develop and organize testing schedules, and coordinate verification and validation resources and lab capacity. Ensure priorities and objectives are communicated clearly; projects are completed on time, and compliance with protocols and overall objectives.
Coordinate with project teams and R&D management to establish Verification/Validation plans in support of NPD and Sustaining projects.
Ensure equipment is functioning properly, calibrated, and all associated documentation is in order.
Oversee the creation, review, approval, and execution of laboratory policies, procedures, and method validations.
Review documentation produced in the laboratory is ensure compliance with applicable cGxPs.
Prepares for and participate in internal and external audits by regulatory authorities (FDA, EU, ISO) and customers.
Responsible for the safety of laboratory personnel/visitors.
Fosters and maintains positive relationships with internal and external colleagues ensuring timely and accurate communication.
Management responsibilities include: Oversee a team of engineers (direct management) and laboratory technicians (indirect via Laboratory Supervisor);
Day-to-day operations of laboratory employees;
Team budgetary responsibility;
Interpret and execute policies for departments/projects;
Recommend and implement new policies or modifications to existing policies;
Provide general guidelines and parameters for staff functioning; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

COVID-19 Vaccination
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
Bachelor%26rsquo;s degree in Engineering
At least 4 years experience with medical device verification and validation testing.
At least 2 years of leadership responsibility (managing directly) preferred
Experience assessing and initiating actions independently and acting as project manager.
Experience using time management skills such as prioritizing, organizing, and tracking details.
Experience applying knowledge of ISO 17025 and CFR requirements; experience interacting with FDA/ISO auditors.
Experience applying knowledge and experience working with USP/ASTM/ISO/AAMI/etc test methods.
Experience applying knowledge of FDA/EU MDR requirements and experience with regulatory interactions as part of medical device regulatory approval process.
Preferred Req%26rsquo;s:
Experience working with medical device design controls and development processes as defined by ISO 13485 and 21 CFR Part 820.
Statistics Experience with basic hypothesis testing and Design of Experiments (DOE) preferred.
Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines.
Technical writing skill and ability.
Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
Ability to present and communicate with various audiences (e.g. senior management and non-technical audiences).

Keywords: Medline Industries, Inc., Arlington Heights , Laboratory Manager Design Verification and Validation R and D, Healthcare , Mundelein, Illinois

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